510(k) · Cleared

Recalled · 2002

Surgisis Peripheral Vascular Patch

K001785510(k) TraditionalCleared Dec 27, 2000197-day reviewClass II21 CFR 870.3470Recalls 1

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Cook Biotech, Inc. · DXZ Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene

Cleared on Dec 27, 2000 after a 197-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 9 later devices descend from it. It has been recalled once.

Decided: Dec 27, 2000
Review: 197 days
Class: Class II
Product code: DXZ
Recalls: 1
Predicates: 0

9 later devices descend from it, 3 citing it directly.

This deviceK001785 Surgisis Peripheral Vascular PatchCook Biotech, Inc. · 2000
Descendant · cites it directly · 6 of its ownK022044 Surgisis Staple Line ReinforcementCook Biotech, Inc. · 2002
Descendant · 2 generations on · 3 of its ownK051048 Surgisis Staple Line Reinforcement IICook Biotech, Inc. · 2005
Descendant · 3 generations on · 2 of its ownK070405 Modification to Surgisis SLR Staple Line ReinforcementCook Biotech, Inc. · 2007
Descendant · 4 generations on · 1 of its ownK170945 Biodesign Staple Line ReinforcementCook Biotech Incorporated · 2017
Descendant · 2 generations on · 1 of its ownK133011 Diaphragmatic Hernia GraftCook Biotech, Inc. · 2014 · Recalled

Showing 5 of 9 descendants. See all descendants

Descendants cleared per year

2002high 2 (2014) · low 0 (2003)2026

Most influential descendants

Showing 5 of 9 · See all

K022044Surgisis Staple Line ReinforcementCook Biotech, Inc. · 2002 · cites it directly6descendants
K051048Surgisis Staple Line Reinforcement IICook Biotech, Inc. · 2005 · 2 generations on3descendants
K070405Modification to Surgisis SLR Staple Line ReinforcementCook Biotech, Inc. · 2007 · 3 generations on2descendants
K170945Biodesign Staple Line ReinforcementCook Biotech Incorporated · 2017 · 4 generations on1descendant
K133011Diaphragmatic Hernia GraftCook Biotech, Inc. · 2014 · 2 generations on1descendant

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K001785	Surgisis Peripheral Vascular Patch	Cook Biotech, Inc.	2000	—
+1	K022044	Surgisis Staple Line Reinforcement	Cook Biotech, Inc.	2002	—
+2	K051048	Surgisis Staple Line Reinforcement II	Cook Biotech, Inc.	2005	—
+3	K070405	Modification to Surgisis SLR Staple Line Reinforcement	Cook Biotech, Inc.	2007	—
+4	K170945	Biodesign Staple Line Reinforcement	Cook Biotech Incorporated	2017	—
+2	K133011	Diaphragmatic Hernia Graft	Cook Biotech, Inc.	2014	1

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2002	1	0
2005	1	0
2007	1	0
2011	1	0
2014	2	0
2017	1	0
2018	1	0
2020	1	0

FIG. 1 — Lineage of K001785, 2000–2020Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in DXZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new DXZ device

#1 K240775 PeriBeam® Pericardial Membranescore 9.2 · 1 generation · no Class I recall
#2 Held for the reportin the report

Get a 510(k) Report

What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (9)

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K022044	Surgisis Staple Line Reinforcement	Cook Biotech, Inc.	2002	6
K111187	Patch, Pledget and Intracardiac	Cormatrix Cardiovascular, Inc.	2011	1
K140789	Cormatrix Ecm for Vascular Repair	Cormatrix Cardiovascular, Inc.	2014	0

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Dec 13, 2002	Not classified	Z-0577-03	Other	Adverse events- suspected pseudoaneurysm

No ancestor or descendant has a Class I recall.

What does this lineage say?

Of its descendants, K022044 (Cook Biotech, Inc., 2002) has gone furthest, with 6 descendants of its own.

How does its category compare?

All DXZ devices

DXZ Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DXZ

1in 2025

2007high 3 (2010) · low 0 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DXZ

106in 2014

2007high 106 (2014) · low 91 (2010)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DXZ

2in 2025

2007high 2 (2010) · low 0 (2007)2026

Class I (2 since 2007) Class II/III not classified

Adverse event reports per year · DXZ

119in 2025

2007high 171 (2015) · low 6 (2008)2025

MAUDE reports naming product code DXZ, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	1	—	0	50
2008	2	—	0	6
2009	1	—	0	109
2010	3	91	2	81
2011	2	—	2	47
2012	1	—	0	21
2013	1	—	2	69
2014	3	106	0	93
2015	2	—	0	171
2016	2	—	0	66
2017	1	—	0	30
2018	0	—	1	44
2019	0	—	0	55
2020	1	—	1	121
2021	0	—	0	80
2022	0	—	0	77
2023	0	—	2	40
2024	0	—	0	49
2025	1	—	2 (2)	119
2026	0	—	1	—

https://510kreport.com/device/K001785 · printed Nov 6, 2026

Cite this page

510(k) Report. “K001785: Surgisis Peripheral Vascular Patch.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K001785

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026